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„ Introduction
„ Medical Devices
„ The artificial kidney
Device Design „ Lasersystems for eye surgery
Andrew Mikhail, Ghazaleh Farid Modjtahedi, „ Drug delivery devices
Joanna Chong, Mike Shleiffer
„ Synthetic blood vessels

„ Summary

Introduction Introduction

„ What is a medical device? „ In the news:

„ An apparatus that aids in diagnostic or
therapeutic medical procedures
“Ultrafast laser detection of cancer cells also may improve
„ Medical device sector covers more than 8000 types of
understanding of stem cells”
“Smart nanocarrier technology for use in cancer treatment”
„ Includes: bandages, surgical tools, imaging (MRI, CT
etc), implantable devices, ventilators, etc. “Patients can now swallow pill-
pill-sized, disposable cameras to help
diagnose diseases of the esophagus”
„ Why are they important? “MicroJet injector for painless injections”
„ Improve health care (New treatments, early diagnosis) “New computer mouse adapter that enables people who suffer
„ Reduce cost of health care from hand tremors to eliminate excessive cursor movement”
„ Improve safety

Diverse area of research with endless possibilities!

Headlines from News-Medical.Net

Introduction The Artificial Kidney

Selected topics Medical Need

„ 60,000 people in the US are waiting for a kidney transplant.
„ >600,000 suffer from Chronic Renal Disease (aka
(aka End-
Renal Disease).
1) The artificial kidney „ Diabetes is the leading cause of kidney disease, with
hypertension second.
2) Laser systems for eye surgery „ Kidney disease is the 9th leading cause of death in the U.S.
„ Average cost of dialysis treatment $45,000 - $50,000/year.
3) Drug delivery devices „ First year expenses associated with a kidney transplant
average $100,000.
4) Synthetic blood vessels „ Lack of kidney donors. Possible transplant rejection.

Need more readily accessible, cheaper solution.

The Artificial Kidney The Artificial Kidney

The Human Kidney Hemodialysis
„ Function: to separate urea, minerals, salts, toxins, and other „ Blood is pumped through cellulose tubing immersed in
waste products from the blood. dialysate fluid, and then back into the patient's vein.
„ Conserve/regulate water, salts, and electrolytes. „ The membrane has a molecular-
molecular-weight cut-
cut-off that will allow
„ Active transport of Na+, PO43- , water by osmosis. most solutes in the blood to pass out of the tubing but retain
„ Process controlled by release of ADH/vasopressin from the proteins and cells.
posterior pituitary gland (in response to inc osmotic pressure „ Anticoagulants are used.
from dehydration)

The Artificial Kidney – Current
The Artificial Kidney
„ Hemodialysis techniques have improved with the Implantable kidney
advancement of membrane technology (ex. Hollow fibers)
„ Small, can be attached in addition to kidney or after removal
of a kidney.
„ Some biocompatibility challenges remain

„ Dialysis still requires 2-

2-3 sessions consisting of several hours
of treatment.
„ Natural kidneys produce some hormones and enzymes.
These are not replaced by dialysis.
„ New initiatives:
„ Implantable artificial kidney
„ Tissue engineered kidney

From: International Renal Research,

The Artificial Kidney – Current

Laser Systems for Eye Surgery
Cell seeded tubule design Medical Need
„ Seed kidney cells within tubules. „ Common ophthalmic conditions:
„ Synthetic tubules act as a scaffold. „ Cataracts
„ Tubules are used within a filtration cartridge. „ Treatment previously commonly made use of
„ Results in improved compatibility and function. ultrasonic instruments to break up cataract.
„ Success of technique relies heavily on operator. Can
damage eye, or result in corneal edema.
Tissue engineered kidney
„ Corneal refractive errors (myopia, hyperopia,
„ Use of human and porcine stem cells. astigmatism and presbyopia)
„ Transplanted into mice. „ Often corrected by use of glasses or mechanical
„ Must be harvested at specific time to develop into organized corrective procedures.
kidney tissue. „ In the year 2000, ~2 million refractive procedures
„ Difficult, and immunological barriers remain. worldwide. >90% were performed using laser

Laser Systems for Eye Surgery Laser Systems for Eye Surgery

The Human Eye Refractive surgery

The Excimer Laser

„ Some meta-
meta-stable compounds rapidly dissociate (under
electrical stimulation) to the ground energy state of the
individual molecules, releasing UV photons.
„ The argon-
argon-fluorine molecule emits light with a wavelength of
193 nm.
„ At this wavelength, ~0.25 µm of corneal tissue is removed
with each pulse.

A human hair with grooves created using an eximer laser

„ This laser can be used to correct malformations of the

Laser Systems for Eye Surgery Laser Systems for Eye Surgery

Refractive surgery Advantages of Laser Treatment

The LASIK procedure „ Extremely precise

„ Combines a lamellar cut into the cornea (using a „ Noninvasive
microkeratome) and corneal correction using the excimer
laser. „ Surgery can be performed on an outpatient basis
„ The cut creates a flap attached to the cornea. in a matter of minutes.
„ The flap is folded back, and heals without sutures. „ Minimal pain or discomfort
„ Short recovery time
„ Reduction of postoperative complications (e.g.
inflammation and infection)

Laser Systems for Eye Surgery
Drug Delivery Devices
– Current Research
Medical Need

„ Attempts are being made to reduce uneven „ Better means for delivering drugs will increase the
ablations that may be caused by beam safety, efficacy, and specificity of therapeutic drug
inconsistencies. use.
„ Eliminate over/under dosing.
„ Eye tracking software is under development to „ Increase convenience, ease of use.
produce increased precision.
„ Reduce side effects.

Drug Delivery Devices Drug Delivery Devices

The Therapeutic Window 1) Mechanical
„ Osmotic pumps
„ Miniature infusion pump based on osmosis
„ Drug released from reservoir at constant rate
„ Often used in the laboratory setting
„ Peristaltic pump
„ Mechanical stimulation using rollers
„ Often used in heart bypass machines or to pump
nutrients into blood
„ Asthma Inhaler
„ Anti-
inflammatories, and bronchodilators
„ Pressurized canister with propellant,

Drug Delivery Devices Drug Delivery Devices
2) Polymers for drug delivery Controlled Release
„ Controlled release
„ Site specificity Diffusion controlled
„ Reservoir devices - Diffusion through membrane
„ Monolithic or matrix devices - Diffusion through bulk polymer
Applications: Oral, parenteral,
parenteral, transdermal,
transdermal, implantable drug delivery Water penetration controlled
„ Swelling systems - Water penetration into polymer (ex. hydrogels)
Chemically controlled
„ Polymer degradation (surface erosion) or combination of erosion
and diffusion (bulk erosion)
„ Pendant chain systems - Combination of hydrolysis of pendant
group and diffusion from bulk polymer
Regulated systems
„ Magnetic or ultrasound - External application of magnetic field or
ultrasound to device
„ Chemical - Use of competitive desorption or enzyme-
enzyme- substrate

Drug Delivery Devices – Current

Drug Delivery Devices
Environmentally triggered specificity
„ Drug release may be triggered by environmental factors „ Tissue engineering
„ Ex. Glucose oxidase tethered to surface reacts with glucose, pH is
„ Drugs can be released as polymer scaffold degrades
reduced, polymer swells, insulin is released from reservoir
„ Can be used for oral administration applications.
„ Use of enteric coatings „ “Pharmacy on a chip”
„ Most absorption in small intestine (higher pH than stomach)
„ Gold membrane covers wells on a chip.
„ Drug can be released at the touch of a button.
„ Langer et al

Synthetic Blood Vessels Synthetic Blood Vessels
Medical Need Human Artery
„ Atherosclerosis is the most common cause of premature mortality
in the Western World.
„ >2 in 5 Americans will die of cardiovascular disease.
„ Coronary artery atherosclerosis is estimated to cause over one
million myocardial infarctions annually.
„ Treatment consists of coronary artery bypass using autologous
blood vessels to circumvent atherosclerotic occlusions.
„ Each year half a million such surgeries are performed in the United
„ Non ideal solution:
„ Need suitable harvest site containing non essential, healthy
blood vessel. Multiple vessels required for multiple bypass.
„ Long term patency of venous grafts is significantly reduced by
autologous graft atherosclerosis, damage caused by surgical
manipulation, and susceptibility to infection.

Synthetic Blood Vessels Synthetic Blood Vessels

Synthetic Grafts EC Seeded Grafts
„ Use of Dacron and ePTFE for large diameter grafts (<5mm).
„ Surface grafted PEO. „ Idea is to seed endothelial cells onto a inner surface of
„ Surface grafted anticoagulants (ex heparin). polymeric scaffold, mimicking the inner surface of normal
„ Thrombolytic coatings (tPA
). blood vessel.
„ Hope to achieve anticoagulant properties.
„ Use of cell adhesion peptides (RGD).
„ Difficulty maintaining cells on surface when exposed to flow.
„ State of endothelial cells (anti-
„ Cell sourcing problem, time to develop.

20mm Dacron graft

Heparin coated graft

Synthetic Blood Vessels Synthetic Blood Vessels
Biological blood vessel Biodegradable scaffolds

„ Constructs mimicking the layers of a native blood vessel „ Stimulate tissue ingrowth in vivo
have been grown. „ Resorption must be time with tissue ingrowth to ensure
„ Collagen shaped onto a tube to act as the medial layer. A maintenance of mechanical strength
layer of fibroblasts around the outside to act as the „ Use of copolymers
adventitial layer. Inner surface seeded with ECs to act as the „ One degrades quickly to stimulate ingrowth while other
intimal layer. degrades slowly to maintain mechanical integrity
„ But, not strong enough. Low burst pressure „ Ex. PGA and PLA coplymers
„ Constructs exposed to cyclic strain or pulsatile conditions
„ Results in collagen and smooth muscle cells organization.
„ Increased burst strength
„ Difficult to reproduce consistently, extensive culture and Tissue engineered blood vessels: En route to
maturation time, cell sourcing difficulties. biological heart replacement??

Summary Questions/Comments

New and improved medical devices are continually

being developed.

The artificial kidney, lasers in eye surgery, drug

delivery devices, and vascular grafts are only a
few examples of the many various medical

These devices are crucial to providing suitable

health care services and improving our standard of